Actively Recruiting

Phase Not Applicable
MALE
NCT06649357

Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate

Led by Fundacio Puigvert · Updated on 2026-04-29

130

Participants Needed

6

Research Sites

291 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Introduction: Multiple studies have demonstrated the superiority of HoLEP in aspects such as transfusión rates or postoperative stay. On the other hand, no differences have been observed in terms of functional outcomes between both techniques, and surgical times reported in different studies tend to be longer for HoLEP. These results likely contribute to TURP, especially with bipolar energy (Bi-TURP), continuing to be considered by many the gold standard for surgical treatment of BPH. Sofware and hardware upgrades to the Lumenis Pulse 120H. system in 2017, delivered MOSES 2.0, a single-use laser fibre used to perform MOSES augmented HoLEP (MoLEP). MoLEP has shown to be superior in intraoperative outcomes when compared to traditional HoLEP. The availability of new morcellators might also decrease surgical time for HoLEP. This changing landscape for BPH endoscopic surgery deserves a re-evaluation of the differences between Bi-TURP and MoLEP. Primary Objective: To compare the hospital stay of patients of patients undergoing MoLEP with those undergoing Bi-TURP. Secondary objectives: * To compare the surgical time of MoLEP with that of Bi-TURP. * To compare the bladder catheterization time aCer MoLEP with that of Bi-TURP. * To compare the postoperative complication rate patients undergoing MoLEP with those undergoing Bi-TURP. * To compare functional results of patients undergoing MoLEP with those undergoing Bi-TURP. This study is a prospective multicentric randomized and controlled trial. The study compares two types of BPH surgery without changing standard medical practice. The study will include patients who are candidates according to standard medical practice for BPH surgery. Patients will be randomized to one of two groups of treatment. * The MoLEP group will receive surgical treatment with MoLEP. * The Bi-TURP group will receive surgical treatment with Bi-TURP. Surgical technique and postoperative care will follow standard clinical practice at each participating centre.

CONDITIONS

Official Title

Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate

Who Can Participate

MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with maximum flow rate < 15 ml/sec before surgery or with flow rate > 15 ml/sec and urodynamic study showing high-flow obstruction (bladder outlet obstruction index > 40)
  • Patients with moderate to severe lower urinary tract symptoms (IPSS score between 8 and 35)
  • Patients with prostate volume between 40 and 80 cc measured by ultrasound or MRI
Not Eligible

You will not qualify if you...

  • History of prior prostatic obstructive or urethral surgery
  • Diagnosis of prostate neoplasia
  • Diagnosis of urothelial neoplasia
  • Lack of flowmetry or IPSS data before surgery
  • Diagnosis or suspicion of hypo/acontractile detrusor before surgery
  • Diagnosis or suspicion of neurogenic bladder or neurological disease
  • History of pelvic radiation therapy

AI-Screening

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Trial Site Locations

Total: 6 locations

1

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain, 15706

Actively Recruiting

2

Fundacio Puigvert

Barcelona, BARCELONA, Spain, 08025

Actively Recruiting

3

Hospital Univesitari de Bellvitge

L'Hospitalet de Llobregat, BARCELONA, Spain, 08907

Not Yet Recruiting

4

Hospital Universitario Marqués de Valdecillas

Santander, Cantabria, Spain, 39008

Actively Recruiting

5

Hospital Universitario de Cabueñes

Gijón, Principality of Asturias, Spain, 33394

Actively Recruiting

6

Hospital Universitario Río Hortega

Valladolid, Valladolid, Spain, 47012

Actively Recruiting

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Research Team

I

Ivan Schwartzmann Jochamowitz, MD

CONTACT

S

Silvia Mateu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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